DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement(s) filed on the record are in compliance with the content requirements of 37 CFR 1.97 and 37 CFR 1.98 and have been considered.
Election/Restrictions
Applicant's election without traverse of Invention I, claims 1-17, in the reply filed on 02/25/2026 is acknowledged.
Claims 1-17 are pending and claims 18-20 are withdrawn.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
"a microneedle size device coupled to the microneedle and configured to set a length of the microneedle extending from the chamber" in claim 1; and
"a temperature control assembly coupled to the reservoir, the temperature control assembly configured to set and maintain a temperature of the reservoir" in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 3, 4, 15, 16 and all claims depending therefrom are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 2, 3, 4, 15 and 16 recite "the microneedle". However, claim 1, upon which the aforementioned claims depend, recite two microneedles (i.e., a microneedle part of the claimed device, and a microneedle formed in-situ). It is not clear what specific microneedle is referenced in the dependent claims.
For the purpose of examination, "the microneedle" in the dependent claims will be interpreted to refer to the microneedle part of the claimed device, rather than the microneedle formed in-situ.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4, 7 and 10-17 are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al (U.S. Pub. 2020/0121769 A1, hereinafter "Chang") in view of Merchant et al (U.S. Pub. 2013/0197427 A1, hereinafter "Merchant").
Regarding claim 1, Chang discloses a device for forming in-situ microneedles in tissue, the device comprising:
a body (shown in Fig. 3, but not specifically labeled, to include the actuator 13, ejector 10, and housing for the display 12 and electrical components 6, 7, 8, 9);
a microneedle coupled to the body (one or more microneedles located on head 10; see Fig. 3), the microneedle positioned within a chamber (head 10) at a distal end of the body; a reservoir 2 (see Fig. 3) coupled to the body, the reservoir adapted for a biomaterial fluid (a variety of bioactive materials and agents described in paras [0007]-[0026], the reservoir in fluid communication with the microneedle (see Figs. 3 and 6);
a first motor 4 (see Fig. 3 and para [0126]) coupled to the body and the reservoir (the motor is coupled to the piston 3 of the reservoir and is supported by the housing components), the first motor configured to activate the reservoir to expel the biomaterial fluid to the microneedle (see para [0126]: motor activates the piston 3 of the reservoir to expel biomaterial into the needle head 1);
a second motor coupled to the body and the microneedle (see para [0610], disclosing that a motor controls the speed and frequency of the needle punctures);
a microneedle size device 5 (see Fig. 3) coupled to the microneedle and configured to set a length of the microneedle extending from the chamber (see para [0126], cam system and dial 5 is used to adjust needle injection depth); and
a user interface (display 12; see Fig. 3) configured to receive input from a user to control the microneedle to penetrate the tissue to inject the biomaterial fluid into the tissue to generate an in-situ microneedle in the tissue (display 12 is a manual or touch screen control panel; it is understood to control the information processor 9 in order to control ejection volume, for example; see para [0126]).
It is noted that Chang does not appear to disclose a temperature control assembly coupled to the reservoir, the temperature control assembly configured to set and maintain a temperature of the reservoir.
Merchant discloses a microneedle device and a reservoir, comprising a temperature control assembly coupled to the reservoir, and configured to set and maintain a temperature of the reservoir (see para [0077], disclosing an active heating/cooling mechanism to control the temperature of the fluid at a predetermined setting).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Chang, by incorporating a temperature control assembly coupled to the reservoir, the temperature control assembly configured to set and maintain a temperature of the reservoir, in order to control the temperature of the fluid within the reservoir, thereby promoting a desired therapeutic and/or material effect of the fluid within the reservoir).
Regarding claim 2, Chang, in view of Merchant discloses the device of claim 1, wherein the microneedle is configured to reciprocate and extend from a distal end of the device to penetrate the tissue (see para [0610], disclosing that the home position of the needle and the traveling length of the needle will be controlled by variable configurations in a slider crank mechanism).
Regarding claim 3, Chang, in view of Merchant discloses the device of claim 1, wherein the user interface is configured to receive input to control a speed, a depth, a residence time, or a combination thereof of the microneedle (display 12 is a manual or touch screen control panel; it is understood to control the information processor 9 to ensure proper dosage control, width and depth control, speed control, composition and formulation control and any safety measures, as in para [0609]).
Regarding claim 4, Chang, in view of Merchant discloses the device of claim 1, further comprising a controller configured to coordinate communication between the first motor, the second motor, and the microneedle (information processor 9 ensures proper dosage control, width and depth control, speed control, composition and formulation control and any safety measures, which are understood to require coordination between the motors and the microneedle which affect the aforementioned control variables).
Regarding claim 7, Chang in view of Merchant discloses the device of claim 1, wherein the device is configured to be handheld by a user or the device is configured to be controlled by the user through a robotic assembly (see para [0124], disclosing that the device is handheld; and see para [0585], disclosing that the device can be handheld or remotely operated using robotic technology).
Regarding claim 10, Chang in view of Merchant discloses the device of claim of claim 1, wherein the biomaterial fluid comprises a polymer (see para [0198], disclosing collagen; see also para [0473], disclosing protein).
Regarding claim 11, Chang in view of Merchant discloses the device of claim 10, wherein the polymer comprises a synthetic polymer, a naturally occurring polymer, or a combination thereof (collagen and protein can be either synthetic or naturally occurring).
Regarding claim 12, Chang in view of Merchant discloses the device of claim 1, wherein the biomaterial fluid comprises a biologically active agent, a particle-laden solution, or a combination thereof (see paras [0056]- [0061] and [0083]-[0098]).
Regarding claim 13, Chang in view of Merchant discloses the device of claim 12, wherein the biologically active agent comprises a protein (see para [0473]), a carbohydrate (see para [0007] disclosing hyaluronic acid), a small molecule drug (see para [0057] disclosing minoxidil), a cell (see para [0007] disclosing stem cells), or a combination thereof.
Regarding claim 14, Chang in view of Merchant disclose the device of claim 1, wherein the biomaterial fluid has a viscosity of less than 1 Pa.s or has a shear thinning property (see disclosure of micro hyaluronic acid FCH, which has sheer thinning properties by virtue of its ultra-low viscosity)
Regarding claim 15, Chang in view of Merchant disclose the device of claim 1, , wherein the microneedle has a hollow core (see para [0486] disclosing that the device includes hollow needles).
Regarding claim 16, Chang in view of Merchant disclose the device of claim 1, The device of claim 1, wherein the device includes a plurality of the microneedles (see Fig. 3 showing a plurality of the same microneedles located on head 10).
Regarding claim 17, Chang in view of Merchant disclose the device of claim 1, further comprising a crosslinking source (see para [0236] disclosing a composition with a protein cross-linking agent), wherein the crosslinking source comprises a chemical source (a protein cross-linking agent as previously described).
Claims 5, 6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Chang in view of Merchant, further in view of Hynes et al (U.S. Pub. 2006/0271014 A1, hereinafter "Hynes").
Regarding claim 5, Chang, in view of Merchant discloses the device of claim 1, further comprising an assembly, and wherein the reservoir is removably coupled to the body, but does not appear to disclose that the assembly includes the temperature control assembly which is also removably coupled to the body.
Further, regarding claim 6, Chang, in view of Merchant discloses the device of claim 5, but does not appear to disclose that the reservoir includes a syringe, and wherein the temperature control assembly includes a syringe heater and a thermal insulating case, wherein the syringe includes the biomaterial fluid, and wherein the syringe heater is configured to provide heat to the syringe.
Further, regarding claim 9, Chang in view of Merchant does not appear to disclose the device of claim 1, wherein the temperature control assembly is configured to maintain a temperature of the biomaterial fluid at about 4 degrees C to about 80 degrees C.
Hynes discloses a syringe for delivering a medical fluid, comprising a temperature control assembly for providing heat to the syringe, in the form of a removable heater (e.g., phase change material 52 located in compartment 58; see para [0036] and Fig. 3) and thermal insulating case 54 (see Fig. 3).
Hynes further discloses that the medical fluid held in the syringe are heated to about 21 degrees C and/or 37 degrees C (see para [0030]).
A skilled artisan would have found it obvious at the time of the invention to provide the temperature control assembly to be removable with the reservoir, as taught in Hynes, in order to reduce the cooling rate of medical fluid held inside the syringe, such as for reducing the viscosity of the fluid (see Hynes at para [0003]) with a reasonable expectation of success.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Chang in view of Merchant, further in view of Cleary et al (U.S. Pub. 20050228340 A1, hereinafter "Cleary").
Regarding claim 8, it is noted that Chang in view of Merchant does not appear to disclose that the reservoir comprises at least two different biomaterial fluids.
Clearly discloses a device for delivering drugs to the body, comprising a reservoir 18 (see Fig. 9) that can contain multiple separate compartments 18a, 18b to hold two or more different ingredients (see para [0084]).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Merchant in view of Cleary, at the reservoir comprises at least two different biomaterial fluids, in order to utilize the delivery of multiple ingredients that may not be compatible with one another (see Clearly at para [0084]), with a reasonable expectation of success.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hoffmann et al (U.S. Pub. 2017/0224935 A1, hereinafter "Hoffmann") discloses a device for forming in-situ microneedles in tissue, the device comprising:
a body 18 (see Figs. 10 and 13);
a microneedle 24 coupled to the body (see Fig. 10 and para [0157]), the microneedle positioned within a chamber 14 (see Fig. 13) at a distal end of the body;
a reservoir 16 (see Fig. 13) coupled to the body, the reservoir adapted for a biomaterial fluid (a variety of bioactive materials and agents described in at least paras [0064], [0188]-[0192] and [0223]) the reservoir in fluid communication with the microneedle (see para [0070]);
a first motor 42 (see Fig. 6) coupled to the body and the reservoir (the motor is coupled to the piston 46 of the reservoir and is supported by the body), the first motor configured to activate the reservoir to expel the biomaterial fluid to the microneedle (see para [0082], disclosing that movement of the proximal and distal motors 44 and 42 causes threaded rod 46 to move and hence the plunger 48 to extend into the chamber 20 and push the contents of the chamber out through the microneedle 24);
a second motor 44 coupled to the body and the microneedle (see para [0083], disclosing that the motor 44 causes the first motor 42, cartridge and chamber 14 housing the microneedle 24 to move distally and/or proximally);
and a user interface 62 (see Fig. 14 and para [0142]) configured to receive input from a user to control the microneedle to penetrate the tissue to inject the biomaterial fluid into the tissue to generate an in-situ microneedle in the tissue (see paras [0143]-[0151]; although Hoffmann does not appear to explicitly disclose the generation of an in-situ microneedle in the tissue, the device of Hoffmann (with the exception of the microneedle size device) is the same as that which is claimed, and would therefore be able to perform the same function of generating an in-situ microneedle in the tissue).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 03/10/2026